Welcome to our dedicated page for Soligenix news (Ticker: SNGX), a resource for investors and traders seeking the latest updates and insights on Soligenix stock.
Soligenix, Inc. (NASDAQ: SNGX) is repeatedly described in its public communications as a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. News about SNGX often centers on progress across its two segments, Specialized BioTherapeutics and Public Health Solutions, and provides updates on clinical trials, regulatory designations, advisory boards and financing activities.
In the Specialized BioTherapeutics segment, recent press releases highlight the ongoing confirmatory Phase 3 FLASH2 study of HyBryte™ (SGX301, synthetic hypericin sodium) for cutaneous T-cell lymphoma (CTCL), including enrollment milestones and interim safety reviews. Additional news covers Phase 2a clinical results for SGX302 in mild-to-moderate psoriasis, emphasizing improvements in standard psoriasis indices with synthetic hypericin-based photodynamic therapy, and publications and regulatory designations for SGX945 (dusquetide) in Behçet's Disease, including orphan drug designation from the FDA.
Coverage of Soligenix also includes updates on its innate defense regulator (IDR) technology platform, describing dusquetide’s role in modulating the innate immune response, and on its Public Health Solutions programs such as the RiVax® ricin toxin vaccine candidate, filovirus vaccines and CiVax™ for COVID-19, which use the ThermoVax® heat-stabilization platform and have received support from agencies like NIAID, DTRA and BARDA.
Investors following SNGX news can expect announcements about clinical trial milestones, peer-reviewed publications, FDA orphan and fast track designations, medical advisory board expansions in CTCL, as well as capital markets events such as public offerings and Nasdaq listing compliance updates. Bookmarking the SNGX news page on Stock Titan can help track these developments in one place as the company advances its rare-disease and biodefense pipeline.
Soligenix (Nasdaq: SNGX) announced that two lead investigators will present findings from additional supportive trials of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL) at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland on October 9-11, 2024.
Dr. Ellen Kim will present a poster with expanded preliminary results from an investigator-initiated study (RW-HPN-MF-01) at the University of Pennsylvania. Dr. Brian Poligone will give an oral presentation on results from two expanded treatment studies (HPN-CTCL-02 and HPN-CTCL-04) conducted at the Rochester Skin Lymphoma Medical Group.
These presentations will elaborate on findings demonstrating the utility of longer treatment times, the lack of significant systemic exposure to hypericin after topical application, and its relative efficacy and tolerability compared to Valchlor®.
Soligenix (Nasdaq: SNGX) has announced a partnership with Sterling Pharma Solutions to optimize and implement commercially viable, scalable production technology for synthetic hypericin. This active ingredient is used in Soligenix's topical drug product formulations HyBryte™ and SGX302, which are being developed to treat cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively.
The collaboration aims to transfer and optimize manufacturing processes and analytics for GMP manufacturing for clinical trials, with the intention of establishing a long-term commercial manufacturing partnership. This partnership is expected to help Soligenix expand its synthetic hypericin manufacturing capabilities, scale up the process, and reduce costs of goods.
The partnership will support the advancement of Soligenix's topical hypericin clinical programs, particularly HyBryte™ for early-stage CTCL treatment, towards potential worldwide commercialization.
Nova Minerals and Soligenix interviews will air on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on September 21, 2024, at 7 p.m. ET. Nova Minerals, with its Estelle Gold Project in Alaska, holds a 5.2 million ounce gold resource and trades at A$6 per ounce, significantly below the sector average. The company is conducting a Feasibility Study to optimize project economics.
Soligenix, a late-stage biopharmaceutical company, has products targeting a potential $2 billion in annual global sales. Their lead product, HyBryte™, for cutaneous T-cell lymphoma, has shown positive Phase 3 results. The company is also developing treatments for psoriasis and Behçet's Disease, and has collaborations for vaccine development, including a filovirus vaccine program that has demonstrated complete protection in non-human primates.
Soligenix (Nasdaq: SNGX) is hosting an exclusive live investor webinar on September 18, 2024, at 4:15 p.m. ET. CEO Christopher J. Schaber will discuss the company's development pipeline and upcoming milestones. Key highlights include:
1. HyBryte™ for cutaneous T-cell lymphoma (CTCL), with positive Phase 3 results and a follow-up study planned.
2. SGX302 for psoriasis, currently in Phase 2a trials.
3. SGX945 for Behçet's Disease, with a Phase 2a study starting this year.
4. ThermoVax® heat stable vaccine platform technology.
The company's pipeline targets a potential $2 billion in annual global sales. Investors can register for the free webinar and submit questions in advance.
Soligenix (NASDAQ: SNGX) has been granted a European patent for its novel method of producing synthetic hypericin, the active ingredient in HyBryte™, a photodynamic therapy for cutaneous T-cell lymphoma (CTCL). This patent (EP3423428) complements a similar US patent and is expected to expire in 2036. HyBryte™ is a first-in-class treatment that uses visible light to activate hypericin applied to CTCL skin lesions, avoiding risks associated with DNA-damaging chemotherapies and UV-dependent therapies.
The company is set to initiate a confirmatory Phase 3 clinical trial (FLASH2) for HyBryte™ in Q4 2024, following statistically significant efficacy results in a previous Phase 3 trial. Soligenix aims to address the unmet medical need in CTCL, an orphan disease, with support from organizations like the Cutaneous Lymphoma Foundation.
RedChip Companies will air interviews with Soligenix Inc. (Nasdaq:SNGX) and American Resources Corp. on Bloomberg TV on August 17, 2024. Soligenix, a late-stage biopharmaceutical company, highlights its strong portfolio with products targeting a potential $2 billion in annual global sales. Key developments include:
1. HyBryte™, a photodynamic therapy for cutaneous T-cell lymphoma, with positive Phase 3 results and $250 million market potential.
2. SGX302 for psoriasis in Phase 2a trial, with over $1 billion market potential.
3. SGX945 for Behçet's Disease, entering Phase 2a later this year.
4. Collaborations and non-dilutive funding supporting vaccine development, including a filovirus vaccine program showing complete protection in non-human primates.
Soligenix (Nasdaq: SNGX) reported its Q2 2024 financial results and recent accomplishments. Key highlights include:
1. Positive clinical results from a comparability study of HyBryte™ vs. Valchlor® in CTCL treatment, showing a three-fold higher response rate and better safety profile.
2. Upcoming initiation of a confirmatory Phase 3 study for HyBryte™ in early-stage CTCL.
3. Planned Phase 2 study of SGX945 in Behçet's disease, with top-line results expected in H1 2025.
4. Q2 2024 financial results: revenues of <$0.1M, net loss of $1.6M ($1.31 per share), and cash position of $9.1M as of June 30, 2024.
5. Regained compliance with Nasdaq's Minimum Bid Price Rule.
Soligenix, a late-stage biopharmaceutical company, announced promising interim results for its HyBryte™ treatment in an open-label, investigator-initiated study for early-stage cutaneous T-cell lymphoma (CTCL). Supported by a $2.6 million FDA Orphan Products Development Grant, the study evaluated HyBryte™ treatment extended up to 12 months. Six patients have been enrolled, with 75% of patients who completed at least 12 weeks of therapy achieving 'Treatment Success,' defined as a ≥50% improvement in their cumulative mCAILS score. The treatment has been well-tolerated with no adverse events reported. The study aims to enroll up to 50 patients and will provide additional data as it progresses.
Soligenix announced positive results from a comparative study evaluating HyBryte™ against Valchlor® for treating cutaneous T-cell lymphoma (CTCL). The open-label study involved 10 patients over a 12-week treatment period. Results showed that 60% of HyBryte™ patients achieved a 50% or greater improvement in their mCAILS score, compared to 20% for Valchlor®. HyBryte™ also demonstrated a more favorable safety profile, with no adverse events reported, while 60% of Valchlor® patients experienced therapy-related adverse events. The study supports previous Phase 2 and 3 findings and sets the stage for a Phase 3 placebo-controlled study later this year.
Soligenix, a biopharmaceutical firm, announced that Professor Axel Lehrer will present key data on the company's thermostable vaccine platform at the ASM Microbe Conference, June 13-17, 2024. The discussion will include results from the filovirus vaccine candidates SuVax™ and MarVax™ for Sudan ebolavirus and Marburg marburgvirus. These vaccines, developed with the University of Hawaiʽi, use a thermostabilization method that enables stability at higher temperatures, simplifying logistics. The vaccines have shown complete protection in non-human primate studies. Soligenix has also received Orphan Drug Designation for these vaccines.